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Bio-Techne Announces Publication of ExoDx™ Prostate (IntelliScore) EPI Test Clinical Utility Study

On May 7, 2020 Bio-Techne Corporation (NASDAQ:TECH) reported a major publication in the Journal of Prostate Cancer and Prostatic Diseases entitled, Clinical Utility of the exosome based ExoDx Prostate (IntelliScore) EPI test in men presenting for initial Biopsy with a PSA 2-10ng/mL (link available here) (Press release, Bio-Techne, MAY 7, 2020, View Source [SID1234557255]). Principal investigators Dr. Ronald Tutrone, Medical Director of Chesapeake Urology, and Dr. James McKiernan, Professor of Urology at Columbia University, demonstrated the ExoDx Prostate test, or EPI, delivered improved patient outcomes over standard of care in a real-world clinical setting that included 72 urologists, 24 sites and more than 1000 patients. The study is the first ever prospective, multi-center, randomized prostate biomarker trial with a blinded control arm conducted in a clinical utility setting, The study was a collaboration between the largest urology practice in Maryland, Chesapeake Urology, and CareFirst Blue Cross Blue Shield of Maryland.

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The EPI test is a urine-based genomic test that helps inform the prostate biopsy decision. This liquid biopsy test recently received coverage for the VA Healthcare system under the General Services Administration (GSA) award, received a positive coverage decision from Medicare, and is included in the National Comprehensive Cancer Network (NCCN) guidelines for early detection in men for both initial and repeat biopsy. It is performed by Exosome Diagnostics, a Bio-Techne brand, in its CLIA, ISO, and NY certified and CAP-accredited laboratory located in Waltham, Massachusetts. The EPI test is a risk assessment tool that assists physicians and their patients with determining if a prostate biopsy is needed when presented with an ambiguous PSA test result, thereby reducing complications from unnecessary and invasive procedures.

Key findings from the study include:

When implementing the ExoDx Prostate test in a real-world clinical setting, patients demonstrated improved compliance with the physician’s recommendation to defer prostate biopsy when the test was negative and go through with a biopsy when the test was positive.
Twenty-three percent of patients deferred a biopsy due to the EPI test based on the physician-patient shared decision questionnaire.
In the standard of care setting, many high-grade prostate cancers are missed because not all high-risk men go through with a biopsy.
Due to improved compliance to proceed to biopsy, physicians detected 30% more cases of clinically significant, or high-grade prostate cancer compared to the standard of care control arm.
These findings can have significant implications for both clinical and economic outcomes. According to Dr. Ronald Tutrone, "From a clinical perspective, deferring biopsy can help a patient avoid the undesirable complications from a biopsy, such as pain, hematuria, infection and potentially hospitalization. Many patients are frightened to undergo biopsy procedure; however, introducing an EPI result not only improved compliance to proceed to biopsy, but detected more clinically significant cancers that might have been missed under the standard of care paradigm."

"This study has important implications from an economic perspective," commented Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "Avoiding unnecessary biopsy procedures represents an estimated savings to the healthcare system of $1,400-$4,000 per patient, in addition to added costs treating complications. There are economic consequences to missing high grade prostate cancer as well. Risk stratification tools such as the ExoDx Prostate test provide the right intervention for the right patient at the right time. Publication of this study in a leading urology journal confirms our convictions that the ExoDx Prostate test provides strong clinical utility and economic value to patients, the medical community and private payors."

A nationwide webinar is scheduled for May 21, 2020 to review the study findings in detail. More information can be found on the Exosome Diagnostics website at View Source

Monopar Therapeutics Reports First Quarter 2020 Financial Results and Business Updates

On May 7, 2020 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported first quarter 2020 financial results and business updates (Press release, Monopar Therapeutics, MAY 7, 2020, View Source [SID1234557254]).

First Quarter and Recent Highlights

Validive Phase 2b/3 Clinical Trial

Monopar, in response to the current COVID-19 pandemic and its effects on clinical trials, has modified the original adaptive design Phase 3 clinical trial to be a Phase 2b/3 clinical trial to better fit the types of trials which can enroll patients in the current environment.

The primary endpoint, absolute incidence of severe oral mucositis, remains the same, but the touch points with the healthcare system have been minimized.

The Validive program will now consist of a randomized Phase 2b/3 clinical trial anticipated to start in the second half of 2020, which will have an unblinded data readout after the Phase 2b portion (estimated to be in the second half of 2021), and shortly thereafter the Phase 3 portion will commence subject to the Company’s ability to raise additional funding or find a suitable pharmaceutical partner.
Camsirubicin Phase 2 Clinical Trial

Camsirubicin clinical program continues to make progress with its collaboration with Grupo Español de Investigación en Sarcomas (GEIS), an internationally renowned non-profit organization focused on the research and development of drugs for sarcoma cancers, which is sponsoring the approximately 170-patient camsirubicin Phase 2 clinical trial for the treatment of advanced soft tissue sarcoma, anticipated to begin in the second half of 2020.
"We are excited to move our clinical development programs forward, especially in light of the challenges that the COVID-19 pandemic has created for many biopharmaceutical companies. Addressing the needs of oncology patients is our highest priority and we look forward to entering the clinic in the second half of this year," said Andrew Mazar, Ph.D., Monopar’s Chief Scientific Officer.

First Quarter Summary Financial Results

Results for the Quarter Ended March 31, 2020 Compared to the Quarter Ended March 31, 2019

Cash and cash equivalents as of March 31, 2020 were $12.6 million. Net loss for the three months ended March 31, 2020 was $1.1 million or $0.10 per share compared to net loss of $1.4 million or $0.15 per share in the comparable period in 2019.

Research and Development (R&D) Expenses

R&D expenses for the three months ended March 31, 2020 were $0.3 million, compared to $0.8 million, for the three months ended March 31, 2019. This represents a decrease of $0.5 million primarily attributed to a decrease in Validive clinical trial planning and accrued material costs.

General and Administrative (G&A) Expenses

G&A expenses for the three months ended March 31, 2020 were $0.8 million, compared to $0.6 million, for the three months ended March 31, 2019. This represents an increase of $0.2 million primarily attributed to increases in professional fees and G&A cash and stock-based (non-cash) compensation.

West to Participate in Upcoming Investor Conferences

On May 7, 2020 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported it will participate in the Bank of America Securities 2020 Healthcare Conference on Thursday, May 14, 2020, as well as the Jeffries Virtual Healthcare Conference 2020 on Tuesday, June 2, 2020 (Press release, West Pharmaceutical Services, MAY 7, 2020, View Source [SID1234557206]). Management will participate in virtual presentations at both events.

A live audio webcast will be available in the "Investors" section of the Company’s website at www.westpharma.com. Replay of the webcasts will be available for approximately 90 days after the events.

Vivoryon Therapeutics AG to Publish its First Quarter 2020 Business Update on May 14, 2020

On May 7, 2020 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY, ISIN DE0007921835), which develops first-in-class drugs targeting post-translational modifying enzymes, reported that it will publish its first quarter business update for the period ended March 31, 2020 on Thursday, May 14, 2020, in the form of an interim management report (Press release, Vivoryon Therapeutics, MAY 7, 2020, View Source [SID1234557205]).

New data at the ASCO20 Virtual Scientific Program reflects Roche’s commitment to accelerating progress in cancer care

On May 7, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data from clinical trials of 19 approved and investigational medicines across 21 cancer types, will be presented at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program organised by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which will be held 29-31 May, 2020 (Press release, Hoffmann-La Roche, MAY 7, 2020, View Source [SID1234557204]). A total of 120 abstracts that include a Roche medicine will be presented at this year’s meeting.

"At ASCO (Free ASCO Whitepaper), we will present new data from many investigational and approved medicines across our broad oncology portfolio," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "These efforts exemplify our long-standing commitment to improving outcomes for people with cancer, even during these unprecedented times. By integrating our medicines and diagnostics together with advanced insights and novel platforms, Roche is uniquely positioned to deliver the healthcare solutions of the future."

Together with its partners, Roche is pioneering a comprehensive approach to cancer care, combining new diagnostics and treatments with innovative, integrated data and access solutions for approved medicines that will both personalise and transform the outcomes of people affected by this deadly disease.

Key presentations
First results of tiragolumab, Roche’s novel cancer immunotherapy designed to bind to TIGIT, will be shared. These results, from the phase II CITYSCAPE study, examine tiragolumab in combination with Tecentriq (atezolizumab) compared with Tecentriq alone as an initial treatment for people with PD-L1-positive locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC). In addition, updated five-year overall survival rates with Alecensa (alectinib) in people living with treatment-naive anaplastic lymphoma kinase (ALK)-positive metastatic/advanced NSCLC will be presented. With five approved lung cancer medicines and an extensive pipeline across multiple subtypes, Roche’s ultimate aim is to provide an effective treatment option for each person diagnosed with the disease, tailored to the unique characteristics of their tumours.

Studies featured from partnerships with Flatiron Health and Foundation Medicine demonstrate how the use of next-generation sequencing (NGS) may help inform treatment decisions, optimise testing and enable personalised therapy, including an ongoing additional study designed to prospectively link longitudinal, real-world clinical data with genomic, imaging and outcomes data for patients with advanced lung cancers. The study is monitoring circulating tumour DNA (ctDNA) using FoundationOne Liquid, and tumour tissue samples will be genomically profiled using FoundationOne CDx.

Further information on Roche’s contribution to the ASCO (Free ASCO Whitepaper) 2020 scientific programme, as well as the latest innovations and developments in Roche’s approach to accelerating progress in cancer care, will be featured during the Roche virtual analyst event from 5:00 – 6:15 pm CEST on Friday,29 May. Further details are available here

To access Roche’s ASCO (Free ASCO Whitepaper) virtual newsroom, please register via this link: View Source

Follow Roche on Twitter via @Roche and keep up to date with ASCO (Free ASCO Whitepaper) news and updates by using the hashtag #ASCO20.

Overview of key presentations featuring Roche medicines at ASCO (Free ASCO Whitepaper) 2020

Medicine Abstract title Abstract number
Lung cancer
Tiragolumab Primary analysis of a randomized, double-blind, phase II study of the anti-TIGIT antibody tiragolumab (tira) plus atezolizumab (atezo) versus placebo plus atezo as first-line (1L) treatment in patients with PD-L1-selected NSCLC (CITYSCAPE) #9503
Oral abstract session

Alecensa (alectinib) Updated overall survival (OS) and safety data from the randomized, phase III ALEX study of alectinib (ALC) versus crizotinib (CRZ) in untreated advanced ALK+ NSCLC #9518
Poster: 284
Poster discussion session
Tecentriq (atezolizumab) Patient-reported outcomes (PROs) in the randomized, phase III IMpower110 study of atezolizumab (atezo) vs chemotherapy in 1L metastatic NSCLC #9594
Poster: 360
Poster session
Tecentriq IMpower150: exploratory analysis of brain metastases development #9587
Poster: 353
Poster session
Tecentriq IMpower150: exploratory efficacy analysis in patients (pts) with bulky disease N/A
e-publication
Flatiron Health data in lung cancer
Real World Data A multi-stakeholder platform to prospectively link longitudinal real-world clinico-genomic, imaging, and outcomes data for patients with metastatic lung cancer #TPS2087
Poster: 79
Poster session
Real World Data Genomic testing among patients (pts) with newly diagnosed advanced non-small cell lung cancer (aNSCLC) in the United States: a contemporary clinical practice patterns study #9592
Poster: 358
Poster session
Solid tumours
Rozlytrek (entrectinib) Updated entrectinib data in children and adolescents with recurrent or refractory solid tumors, including primary CNS tumor #107
Clinical science symposium
Rozlytrek Efficacy and safety of entrectinib in patients (pts) with NTRK-Fusion-Positive (NTRK-fp) solid tumors: An updated integrated analysis #3605
Poster: 335
Poster session
Genitourinary and gastrointestinal cancers
Tecentriq IMvigor010: primary analysis from a phase III randomized study of adjuvant atezolizumab (atezo) versus observation (obs) in high-risk muscle-invasive urothelial carcinoma (MIUC) #5000
Oral abstract session

Tecentriq Tumor, immune, and stromal characteristics associated with clinical outcomes with atezolizumab (atezo) + platinum-based chemotherapy (PBC) or atezo monotherapy (mono) versus PBC in metastatic urothelial cancer (mUC) from the phase III IMvigor130 study #5011
Clinical science symposium
Tecentriq Phase Ib/II open-label, randomized evaluation of 2L atezolizumab + PEGPH20 versus control in MORPHEUS-pancreatic ductal adenocarcinoma (M-PDAC) and MORPHEUS-gastric cancer (M-GC) #4540
Poster: 148
Poster session
Tecentriq, Avastin (bevacizumab) Complete responses (CR) in patients receiving atezolizumab (atezo) + bevacizumab (bev) vs sorafenib (sor) in IMbrave150: a phase III clinical trial for unresectable hepatocellular carcinoma (HCC) #4596
Poster: 204
Poster session
Ipatasertib Circulating tumor DNA (ctDNA) dynamics associate with treatment response and radiological progression-free survival (rPFS): Analyses from a randomized phase II trial in metastatic castration-resistant prostate cancer (mCRPC) #5508
Oral abstract session

Blood cancer
Venclexta (venetoclax)

Impact of premature venetoclax (Ven) discontinuation/interruption on outcomes in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL): Phase III MURANO study results #8028
Poster: 361
Poster session
Venclexta, Gazyva (obinutuzumab) Fixed-duration venetoclax-obinutuzumab for previously untreated patients with chronic lymphocytic leukemia: follow-up of efficacy and safety results from the multicenter, open-label, randomized, phase III CLL14 trial #8027
Poster: 360
Poster session
Gazyva Comparison of efficacy and safety with obinutuzumab plus chemotherapy versus rituximab plus chemotherapy in patients with previously untreated follicular lymphoma – Updated results from the phase III Gallium Study #8023
Poster: 356
Poster session
Breast cancer
Kadcyla (trastuzumab emtansine), Perjeta (pertuzumab) Primary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC) #500
Oral abstract session

Kadcyla Biomarker data from KATHERINE: A phase III study of adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab (H) in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer #502
Oral abstract session

About Roche in Oncology
Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast.

The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa (alectinib); Avastin (bevacizumab); Cotellic (cobimetinib); Erivedge (vismodegib); Gazyva/Gazyvaro (obinutuzumab); Herceptin (trastuzumab); Kadcyla (trastuzumab emtansine); MabThera/Rituxan (rituximab); Perjeta (pertuzumab); Polivy (polatuzumab vedotin-piiq); Tarceva (erlotinib); RozlytrekTM (entrectinib); Tecentriq (atezolizumab); Venclexta/Venclyxto (venetoclax); Xeloda (capecitabine); Zelboraf (vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies. For more information on Roche’s approach to cancer, visit www.roche.com.

About Roche in Personalised Healthcare
For more than 20 years, Roche has helped lay the scientific groundwork for personalised healthcare with treatments that target the underlying biology of cancer and other diseases. Now, with profound changes in data and technology transforming how medicines are discovered, developed and delivered to patients, we are uniquely positioned to extend this approach across all of healthcare. With our ability to integrate research and development, personalised diagnosis, disease monitoring and treatment access, we are advancing personalised healthcare for every aspect of the patient experience.

Our strategy is rooted in groundbreaking science that can accelerate drug discovery and development. We are also leveraging technologies such as real-world datasets, artificial intelligence, genomic profiling and digital health across our therapeutic portfolio, with an initial emphasis on oncology, neurology, ophthalmology and diagnostics. Through collaborations with academic institutions, industry partners, patients, physicians and regulatory agencies, our goal is to dramatically improve the performance of the entire healthcare ecosystem and the lives of every patient.